Toujeo Solostar Patent Expiration

Toujeo Solostar is a drug owned by Sanofi Us Services Inc. It is protected by 21 US drug patents filed from 2015 to 2019. Out of these, 5 drug patents are active and 16 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 16, 2035. Details of Toujeo Solostar's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10369291 Mechanism for a drug delivery device
Sep, 2035

(10 years from now)

Active
US9345750 Long-acting formulations of insulin
May, 2031

(6 years from now)

Active
US7918833

(Pediatric)

Pen-type injector
Mar, 2028

(3 years from now)

Active
US7918833 Pen-type injector
Sep, 2027

(2 years from now)

Active
US8679069 Pen-type injector
Apr, 2025

(3 months from now)

Active
US8512297 Pen-type injector
Sep, 2024

(2 months ago)

Expired
US9561331 Drive mechanisms suitable for use in drug delivery devices
Aug, 2024

(3 months ago)

Expired
US9623189 Relating to drive mechanisms suitable for use in drug delivery devices
Aug, 2024

(3 months ago)

Expired
US9533105 Drive mechanisms suitable for use in drug delivery devices
Aug, 2024

(3 months ago)

Expired
US9604009 Drive mechanisms suitable for use in drug delivery devices
Aug, 2024

(3 months ago)

Expired
US8992486 Pen-type injector
Jun, 2024

(6 months ago)

Expired
US9011391 Pen-type injector
Mar, 2024

(8 months ago)

Expired
US8556864 Drive mechanisms suitable for use in drug delivery devices
Mar, 2024

(9 months ago)

Expired
US9233211 Relating to a pen-type injector
Mar, 2024

(9 months ago)

Expired
US9408979 Pen-type injector
Mar, 2024

(9 months ago)

Expired
US9604008 Drive mechanisms suitable for use in drug delivery devices
Mar, 2024

(9 months ago)

Expired
US9775954 Pen-type injector
Mar, 2024

(9 months ago)

Expired
US8603044 Pen-type injector
Mar, 2024

(9 months ago)

Expired
US9827379 Drive mechanisms suitable for use in drug delivery devices
Mar, 2024

(9 months ago)

Expired
US9526844 Pen-type injector
Mar, 2024

(9 months ago)

Expired
US9610409 Drive mechanisms suitable for use in drug delivery devices
Mar, 2024

(9 months ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Toujeo Solostar's patents.

Given below is the list of recent legal activities going on the following patents of Toujeo Solostar.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 08 Nov, 2023 US9345750
Payment of Maintenance Fee, 4th Year, Large Entity 25 Jan, 2023 US10369291
Post Issue Communication - Certificate of Correction 13 Nov, 2019 US10369291
Payment of Maintenance Fee, 4th Year, Large Entity 08 Nov, 2019 US9345750
Recordation of Patent Grant Mailed 06 Aug, 2019 US10369291
Patent Issue Date Used in PTA Calculation 06 Aug, 2019 US10369291
Email Notification 18 Jul, 2019 US10369291
Issue Notification Mailed 17 Jul, 2019 US10369291
Dispatch to FDC 26 Jun, 2019 US10369291
Application Is Considered Ready for Issue 20 Jun, 2019 US10369291


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Toujeo Solostar and ongoing litigations to help you estimate the early arrival of Toujeo Solostar generic.

Toujeo Solostar's Litigations

Toujeo Solostar been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Sep 10, 2018, against patent number US8992486. The petitioner Mylan Pharmaceuticals Inc et al., challenged the validity of this patent, with Sanofi-Aventis Deutschland GmbH et al. as the respondent. Click below to track the latest information on how companies are challenging Toujeo Solostar's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8679069 May, 2019 FWD Entered
(11 Aug, 2020)
Sanofi-Aventis Deutschland Pfizer Inc.
US8603044 September, 2018 FWD Entered
(29 May, 2020)
Sanofi-Aventis Deutschland GmbH Mylan Pharmaceuticals Inc.
US8992486 September, 2018 FWD Entered
(29 May, 2020)
Sanofi-Aventis Deutschland GmbH Mylan Pharmaceuticals Inc.
US8992486 October, 2018 FWD Entered
(29 May, 2020)
Sanofi-Aventis Deutschland GmbH Mylan Pharmaceuticals Inc.
US9526844 September, 2018 FWD Entered
(29 May, 2020)
Sanofi-Aventis Deutschland GmbH Mylan Pharmaceuticals Inc
US9526844 September, 2018 FWD Entered
(29 May, 2020)
Sanofi-Aventis Deutschland GmbH Mylan Pharmaceuticals Inc.
US9604008 September, 2018 FWD Entered
(29 May, 2020)
Sanofi-Aventis Deutschland GmbH Mylan Pharmaceuticals Inc.
US8679069 September, 2018 FWD Entered
(02 Apr, 2020)
Sanofi-Aventis Deutshland GmbH Mylan Pharmaceuticals Inc.
US9526844 May, 2019 Terminated-Other
(20 Aug, 2019)
Sanofi-Aventis Deutschland Pfizer Inc.
US9526844 May, 2019 Terminated-Other
(19 Aug, 2019)
Sanofi-Aventis Deutschland Pfizer Inc.
US8603044 May, 2019 Terminated-Other
(15 Aug, 2019)
Sanofi-Aventis Deutschland Pfizer Inc.
US8992486 May, 2019 Terminated-Other
(15 Aug, 2019)
Sanofi-Aventis Deutschland Pfizer Inc.
US9604008 May, 2019 Terminated-Other
(15 Aug, 2019)
Sanofi-Aventis Deutschland Pfizer Inc.
US9526844 September, 2018 Terminated-Denied
(03 Apr, 2019)
Sanofi-Aventis Deutschland GmbH Mylan Pharmaceuticals Inc.
US8992486 September, 2018 Terminated
(19 Dec, 2018)
Sanofi-Aventis Deutschland GmbH et al. Mylan Pharmaceuticals Inc et al.


FDA has granted some exclusivities to Toujeo Solostar. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Toujeo Solostar, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Toujeo Solostar.

Exclusivity Information

Toujeo Solostar holds 2 exclusivities. All of its exclusivities have expired in 2022. Details of Toujeo Solostar's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Feb 25, 2018
New Patient Population(NPP) Nov 26, 2022

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US patents provide insights into the exclusivity only within the United States, but Toujeo Solostar is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Toujeo Solostar's family patents as well as insights into ongoing legal events on those patents.

Toujeo Solostar's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Toujeo Solostar's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 16, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Toujeo Solostar Generics:

There are no approved generic versions for Toujeo Solostar as of now.

Alternative Brands for Toujeo Solostar

Toujeo Solostar which is used for managing glycemic control in diabetes mellitus patients., has several other brand drugs in the same treatment category and using the same active ingredient (Insulin Glargine Recombinant). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Sanofi Aventis Us
Apidra Solostar Used for improving glycemic control in diabetes mellitus patients.
Lantus Solostar

(uses Insulin Glargine Recombinant)

Used for improving glycemic control in diabetes mellitus patients.
Sanofi-aventis Us
Soliqua 100/33 Used for improving glycemic control in type 2 diabetes mellitus patients.
Admelog Solostar Used for improving glycemic control in diabetes mellitus patients.
Sanofi Us Services
Toujeo Max Solostar

(uses Insulin Glargine Recombinant)

Used for improving glycemic control in diabetes mellitus patients.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Insulin Glargine Recombinant. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Sanofi Aventis Us
Lantus






About Toujeo Solostar

Toujeo Solostar is a drug owned by Sanofi Us Services Inc. It is used for managing glycemic control in diabetes mellitus patients. Toujeo Solostar uses Insulin Glargine Recombinant as an active ingredient. Toujeo Solostar was launched by Sanofi Us Services in 2015.

Approval Date:

Toujeo Solostar was approved by FDA for market use on 25 February, 2015.

Active Ingredient:

Toujeo Solostar uses Insulin Glargine Recombinant as the active ingredient. Check out other Drugs and Companies using Insulin Glargine Recombinant ingredient

Treatment:

Toujeo Solostar is used for managing glycemic control in diabetes mellitus patients.

Dosage:

Toujeo Solostar is available in solution form for subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
450 UNITS/1.5ML (300 UNITS/ML) SOLUTION Prescription SUBCUTANEOUS